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Published on: September 8, 2021
Analysis of dermatologic events in vemurafenib-treated patients with melanoma
Mario E Lacouture1, Madeleine Duvic, Axel Hauschild
1Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York 10022, USA. lacoutum@mskcc.org
Background:
Vemurafenib has been approved for the treatment of patients with advanced BRAF(V600E)-mutant melanoma. This report by the Vemurafenib Dermatology Working Group presents the characteristics of dermatologic adverse events (AEs) that occur in vemurafenib-treated patients, including cutaneous squamous cell carcinoma (cuSCC).
Methods:
Dermatologic AEs were assessed from three ongoing trials of BRAF(V600E) mutation-positive advanced melanoma. Histologic central review and genetic characterization were completed for a subset of cuSCC lesions.
Results:
A total of 520 patients received vemurafenib. The most commonly reported AEs were dermatologic AEs, occurring in 92%-95% of patients. Rash was the most common AE (64%-75% of patients), and the most common types were rash not otherwise specified, erythema, maculopapular rash, and folliculitis. Rash development did not appear to correlate with tumor response. Photosensitivity occurred in 35%-63% of patients, and palmar-plantar erythrodysesthesia (PPE) occurred in 8%-10% of patients. The severity of rash, photosensitivity, and PPE were mainly grade 1 or 2. In all, 19%-26% of patients developed cuSCC, mostly keratoacanthomas (KAs). The majority of patients with cuSCC continued therapy without dose reduction after resection. Genetic analysis of 29 cuSCC/KA samples demonstrated HRAS mutations in 41%.
Conclusions:
Dermatologic AEs associated with vemurafenib treatment in patients with melanoma were generally manageable with supportive care measures. Dose interruptions and/or reductions were required in <10% of patients.
Insights
Vemurafenib treatment for melanoma commonly causes skin issues like rash and photosensitivity, which are usually manageable. Cutaneous squamous cell carcinoma (cuSCC) also occurred but rarely required treatment changes.
Area of Science:
- Oncology
- Dermatology
- Pharmacology
Background:
- Vemurafenib is approved for advanced BRAF(V600E)-mutant melanoma.
- Dermatologic adverse events (AEs) are common in vemurafenib-treated patients.
- This study characterizes AEs, including cutaneous squamous cell carcinoma (cuSCC).
Purpose of the Study:
- To present characteristics of dermatologic AEs in vemurafenib-treated melanoma patients.
- To analyze the incidence and types of skin AEs.
- To investigate cuSCC development and HRAS mutations.
Main Methods:
- Assessment of dermatologic AEs from three ongoing BRAF(V600E)-mutant advanced melanoma trials.
- Histologic central review of cuSCC lesions.
- Genetic characterization of a subset of cuSCC/keratoacanthoma (KA) lesions.
Main Results:
- 92%-95% of patients experienced dermatologic AEs; rash (64%-75%) and photosensitivity (35%-63%) were most common.
- Cutaneous squamous cell carcinoma (cuSCC) developed in 19%-26% of patients, primarily keratoacanthomas (KAs).
- HRAS mutations were identified in 41% of analyzed cuSCC/KA samples; most patients continued vemurafenib after cuSCC resection.
Conclusions:
- Dermatologic AEs from vemurafenib are generally manageable with supportive care.
- Dose modifications were infrequent (<10% of patients).
- Vemurafenib remains a viable treatment option with manageable dermatologic toxicities.
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